Suture reel-label package

ABSTRACT

Surgical sutures, including ligatures, are wound from a needled or free end on a printed reel-label. The reel-label is made from sealed together thicknesses of stiff inert sterilizable label stock, with means, such as an aperture or grommet, to act as a rotable axis to permit holding between a finger and thumb for unwinding. A needle, if attached, is held in a pocket between the thicknesses with the armed portions of the needle protected. The friction between the thicknesses and the suture permits retention of the suture during storage and unwinding from either end. The suture reel assembly is stored in a sterile envelope which may be completely dry. The thus formed package protects the suture from kinks during storage, it protects the suture from the needle and the package from the needle. It permits unwinding from either end without tangling and it is capable of being rewound.

United States Patent n91 Sonnino SUTURE REEL-LABEL PACKAGE [75]Inventor:

[73] Assignee: American Cyanamid Company.

Stamford. Conn.

[22] Filed: Aug. 8, 1973 [2]] Appl. No.: 386,672

Mario Sonnino, New Canaan. Conn.

[52] U.S. Cl. 206/227; 206/633; 242/159 [51] Int. Cl. A6lb 17/06; A61117/02 (58] Field of Search 206/633. 227

[ 56] References Cited UNITED STATES PATENTS 2.949.l8l 8/l96i) Buccino206/613 3.180.487 4/1965 Uddenborg 206/227 3.185.299 5/1965 Trainer206/633 3.206.0l 8 9/1965 Lewis et a] 206/633 3.648.949 3/l972 Berger eta]. 206/613 X FOREIGN PATENTS OR APPLICATIONS 1.08l.l23 8/1967 UnitedKingdom 206/633 1 Apr. 8, 1975 Primary E.\'aminerLeonard SummerAttorney. Agent. or Firm-Samuel Branch Walker [57] ABSTRACT Surgicalsutures. including ligatures. are wound from a needled or free end on aprinted reel-label. The reellabel is made from sealed togetherthicknesses of stiff inert sterilizable label stock, with means, such asan aperture or grommet. to act as a rotable axis to permit holdingbetween a finger and thumb for unwinding. A needle. if attached. is heldin a pocket between the thicknesses with the armed portions of theneedle protected. The friction between the thicknesses and the suturepermits retention of the suture during storage and unwinding from eitherend. The suture reel assembly is stored in a sterile envelope which maybe completely dry. The thus formed package protects the suture fromkinks during storage. it protects the suture from the needle and thepackage from the needle. lt permits unwinding from either end withouttangling and it is capable of being rewound.

6 Claims, 16 Drawing Figures SUTURE REEL-LABEL PACKAGE BACKGROUND OF THEINVENTION In this modern day of convenience packaging, more and moreeffort is being put into attempting to package in a form which isconvenient and economical and which meets requirements for theparticular item being packaged.

In the packaging of surgical sutures, it is necessary that the suturesbe released in sterile condition, ready for use by the surgeon with theeconomic requirement that the packaging be as economical as consistentwith the qualities required and to the extent possible that a minimum ofnumber pieces and minimum quantity of packaging materials result fromreleasing the suture for use. A count is often kept to insure that eachneedle and each reel and envelope is removed from the operating field.

An acceptable package needs to be inexpensive and completely reliable.The package must release a sterile suture for the surgeon's use with hispositive knowledge that the suture is, in fact, sterile and none of itsdesign characteristics have been compromised during storage prior touse. Sutures may be stored in hospitals for several years before use,although the usual storage time is much shorter.

There are many sizes of sutures, and many materials of construction,such as catgut, or polyglycolic acid for absorables, and non-absorbablesof silk, cotton, nylon, dacron, polyethylene, polypropylene, stainlesssteel, insulated stainless steel, and other materials of construction,There are several different needle types in common use, includingpointed straight, pointed curved, three cornered straight, threecornered curved, both regular and reverse, and needles with side cuttingedges of various types. The variations and combinations of each of theseto meet the preferences of many surgeons for different operativeprocedures means that a suture manufacturer needs to supply differentsuture combinations running into the thousands. Some of these are fastmoving items, others meet only with occasional demand. For purposes ofconvenience and storage in the hospital as well as economy ofmanufacture, it is highly desirable that as many suture combinations asfeasible be packaged in a minimum number of different package styles andshapes and storage units. It is quite common to package three dozenidentical sutures in a box. It is convenient to have most of the boxesabout the same size and shape, so that the hospi tal may store them mostconveniently. It is also convenient from the manufacturers standpoint tobe able to reduce his inventory of box sizes and to be able to use thesame components for the maximum number of suture combinations in theproduct line.

It is essential that a package for a side cutting needle; that is, aneedle which has a sharp edge on the side, protect the suture fromcontact with the sharp side, or armed edge, ofthe needle which couldpartially cut the suture and to avoid having the sharp edges cut thepackage. Also, the armed needle edges need to be protected so as tomaintain their sharpness.

Additionally, it is highly desirable that the needles and sutures beoriented in a consistent relationship within packages so that the usingsurgeon, directly, or the nurse who passes the sutures to the surgeon,will be able to rapidly and reliably grip the needle without having totake time to orient the needle with respect to the needle forceps at thetime of use.

These requirements are so rigorous and of such importance that manydifferent package designs have been tried, some have been used, and manyhave been found wanting in one or more particulars.

Most of the suture packages today are strippable, double envelopepackages of the type first disclosed in U.S. Pat. No. 3,043,067,Rynkiewicz and Ayres, Suture Package, July 10, 1962.

The outer envelope and certain details are disclosed in U.S. Pat. No.2,949,181, Buccino, Suture Package And Process Of Making Same, Aug. I6,1960.

U.S. Pat. No. 3,357,550, Holmes and Murphy, Combination Reel And LabelFor Surgical Sutures", Dec. 12, I967, shows a system in which the reelalso serves as a label with the reel being torn apart to release thesuture wound on the label.

U.S. Pat. No. 3,376,973, Granowitz and Buccino, Package For SurgicalSutures, Apr. 9, I968, shows a molded plastic reel fitting in a hub forsurgical sutures with the assembled reel, hub and suture being packagedin outer envelopes.

U.S. Pat. No. 3,038,475, Orcutt, Surgical Needles And Manufacture OfSame, June l2, l962, shows certain forms of surgical needles, includingcurved, triangular shaped needles with the edges being sharp or roundand which sharp side edges can damage sutures or packages.

U.S. Pat. No. 2,84l,l 50, Riall, Cutting Edge Suture Needle, July 1,1958, shows another type of side cut ting needle, the sharp edges ofwhich can damage sutures or packages.

SUMMARY OF THE INVENTION It has now been found that a suture packagemeeting the requirements set forth above is advantageously formed fromsheet label stock one side of which is coated with a thermoplasticadhesive, such as polyethylene, with either a single sheet of such amaterial being doubled on itself to provide two thicknesses, or twoseparate sheets of material being sealed together and appropriatelyfolded, so that the suture is wrapped between at least two thicknessesof the label stock which are sealed together. The suture is retainedbetween the two sheets of material sealed together, whereby the sutureis held in position until time for use and the suture is readilyunreeled from either end from between the two thicknesses of labelstock. Conveniently. the needled end is placed first and the free end iswound around the reel-label. At the time of use, the needle is pulledfree and the suture is unwound from the needled end with the variousturns of the suture passing each other in the V-groove between the labelstock thicknesses, without tangling and without compromise of suturequality.

In preferred embodiments of the invention, an additional thickness oflabel stock which may be transparent covers and protects the needle fromcontact with either the turns of the suture or the envelope. The needleis inserted in retaining means in the reel-label. The additionalthickness of label stock covers the needle in such fashion that thecovering portion can be turned back to release the needle in orientedrelationship so that it may be picked up by the user in consistentorientation. Any of the usual types of needle forceps may be used.

The reel-Iable having the suture wound thereon may be packaged dry or ina selected tubing fluid in an interiorly and exteriorly sterile innerenvelope. which inner envelope is packaged in a strippable outerenvelope.

As is conventional in the art, the suture is served to a surgeon bystripping the outer envelope, and either with forceps. or by manuallyprojecting, the inner envelope is passed across the sterile barrier,into the sterile areas of the operating room.

The inner envelope is opened at time of use.

As used herein, the term sutures includes ligatures. Ligaturestechnically are used without a needle for tying, whereas sutures areused with a needle for penetration of tissues as well as tying. The samematerial can be used for both purposes and frequently parts of the samestrand are actually used as both a suture and a ligature depending uponthe requirements of the surgeon at a particular time during a surgicalprocedure.

The sutures may have a needle on one or both ends. Frequently a needleis placed on each end so that the suture is cut and each needle usedseparately, and sometimes each needle is used for penetration forparticular tissues at a particular time. Conveniently, the needles areof the eyeless type that is permanently attached to the end of thesuture and designed for but a single use. Such needles cause less traumato tissues in which they are used and are becoming surgically preferred.

The present invention is particularly adapted for the packaging ofpolyglycolic acid sutures. These are a new class of synthetic absorbablesuture which is to be packed and stored dry. The requirement for drynessis disclosed in US. Pat. No. 3,728,839, Glick, Storage Stable SurgicallyAbsorbable Polyglycolic Acid Products". Apr. 24, I973.

The sutures may be collagen, either natural catgut or regeneratedcatgut, which sutures are usually packaed in a conditioning fluid suchas a mixture ofone or more alcohols in water so that the collagen willhave a preferred flexibility Non-absorbable sutures may be packed on thepresent reel-label and include such materials as silk, silicone or waxcoated, or cotton or linen, or one of the newer synthetic materials suchas nylon, polyester. isotactic polypropylene, or linear polyethyl ene.stainless steel wire or other wire, either insulated or bare, or thesuture may be of such other composition as preferred by the surgeon forthe surgical procedure in progress.

The reel-label is preferably of a label paper which is manufactured forsuture labels and is a sterilizable paper designed for either letterpress or offset printing. A paper with a 90 lb. weight basis anddesigned to withstand heat, steam, or gas sterilization withoutdiscoloration, and which accepts alcohol and water insoluble ink issatisfactory. It is preferred that such paper be coated with aboutone-half mil of polyethylene so that it becomes heat scalable. Suchpaper is known in the trade and readily available. The sealing may be byheated dies. or heat may be internally generated by ultrasonic means.

The present reel-label is and remains as a single piece, so that thereis only one piece for disposal. In a preferred embodiment, the innerenvelope which en closes and protects the suture on its reellabel isnotched and fits around the reel-label so that it may be breachedstarting at the notch and torn open without tearing the envelope intomore than one piece so that the inner envelope is a single piece fordiscarding.

It is important that the various pieces be identifiable so that after anoperation, the surgical team can reliably find and count all componentsof packaging as well as surgical needles to be certain that undesiredforeign elements are not sewn into the patient at the time of use.

Time and motion studies show that the serving of a suture using thepresent reel-label is faster and more efficient than with conventionalreels. Saving time reduces the time a patient is in surgery, and, hence,the duration of risk, risks, saves time of the medical operat ing team,and reduces time charges for the operatingtheater, all of which areconducive to better and more economical patient care.

The present reel-label can have size and type designations for thesuture and needle. The reel itself as well as the envelopes and boxesused may be color coded to designate the type of suture material. and/orother useful information.

The present invention, and its advantages are also apparent from thedetailed description of certain embodiments thereof which follow.

THE DRAWINGS In the drawings:

FIG. 1 shows a flat scored cut-out for a rectangular reel-label;

FIG. 2 is a pictorial view of the cut-out of FIG. 1 partially folded;

FIG. 3 is the cut-out of FIG. 1 folded, and sealed to itself as areel-label;

FIG. 4 is a needle protective cover for the reel-label of FIG. 3;

FIG. 5 shows a rectangular reel-label with needle protective cover;

FIG. 6 is a cross-section of FIG. 5 at 6-6;

FIG. 7 shows the cover turned back to expose a curved needle and suturewound on the reel-label;

FIG. 8 is a cross-section of FIG. 7 at 88, but with the cover shownflat;

FIG. 9 shows a rectangular reel-label in a notched tearable innerenvelope in a strippable outer envelope;

FIG. 10 shows the inner envelope of FIG. 9 torn open, and the reel labelbeing removed;

FIG. 11 shows a round reel-label in a double strippable envelope;

FIG. 12 shows three rectangular reel-labels in a single package ofdouble envelopes;

FIG. 13 shows a rectangular reel label;

FIG. 14 shows a cross section of FIG. I3 at l4l4;

FIG. 15 shows a round reel-label;

FIG. 16 shows a crosssection of FIG. 15 at l6l6, and shows a X-rayopaque grommet;

As shown in FIG. I, a reel-label is cut out and scored from a sheet ofstiff material such as pound, sterilizable offset printing paper whichhas thereon a coating of one-half mil polyethylene so that it is heatscalable. The label is conveniently, but not necessarily, die cut fromrolls of paper stock and conveniently may be cut out and printed incontinuous rolls, except for a final cut which is made at the time thelabel is folded and sealed.

As shown in FIG. 1, with the printed side up and the polyethylene coatedside down, face panel 21 has attached thereto along score lines a firstand a second accordion pleat panels 22 and 23, to the second of which isattached the back panel 24. On the other side of the rectangular panelare the third and fourth accordion pleat panels 25 and 26. Conveniently,but not necessarily, the third accordion pleat panel 25 is just slightlywider than the fourth accordion pleat panel 26 so that. in folding, whenadhesively united to the back panel, the edge of the fourth accordionpleat panel is just slightly back of the edge of the back panel toinsure that no edges stick out which can snag a suture being wound onthe reel-label, Conveniently. when the reellabel is being cut, scorelines are formed where the panels are to bend to insure that the bendingoccurs at a designed fold line.

To the top and bottom of the face panel and the back panel are attachedears, respectively, the top face panel ear 27, the bottom face panel ear28, top back panel ear 29, and the bottom back panel ear 30. These earsare attached to the respective panels with score lines 31 being stampedinto the label stock at the time of cutout. These score lines permitaccurately positioned folds to be readily made between the panels. A tabnotch 32 is formed in each of the four ears. A tab 33 is cut on threesides near the top and bottom of each ofthe face and back panelspointing towards the center of the panels.

As shown in FIG. 2, the four ears are folded inwardly against the faceand back panels with the adhesive coated sides coming into the contactand similarly the accordion pleat panels are folded inwardly from eachpanel so that the face and back panels can then be folded towards eachother, as shown in F103, with the adhesive of the face and back panelsbeing sealed to each other at the tabs, through the tab notches 32, inthe upper tab seal zone 34 and the lower tab seal zone 35. This holdsthe face and back panels together in resilient spring-likeconfiguration. The face and back panels and united with side seal zones36 on each side which adhesively unite the accordion pleat panels to theface and back panels for the length of the accordion pleat panels andadhesively unite the panel ears to the respective panels. The seals maybe formed consecutively or concurrently.

The ears are advantageously fractionally smaller than the face and backpanel to which they are adhesively united. Conveniently, they may beabout a sixty-fourth of an inch narrower, so that allowing formanufacturing tolerances in cutting and folding the ears, the ears arenecessarily slightly back from the face and back panels so that nocorners protrude on which the suture can be snagged. The corners may beslightly rounded to reduce the chance of snagging.

The back panel has four intermediate radius rounded corners 37. The facepanel has diagonally oriented two smaller radius rounded corners 38 andtwo diagonal larger radius rounded corners 39. By having the larger andsmaller radii on the front face, as the reel-label is assembled, twocorners have the face panel protruding slightly beyond the back panel sothat they may be lifted easily with the finger and the other two cornerswith a larger radius and, hence, are slightly back of the back panel sothat on each of the corners, one of the panels may be convenientlymanipulated to open up the winding notch 49 between the panels.

Near the center ofthe face panel is a face panel rotating hole 40 andnear the center of the back panel is a back panel rotating hole 41.These holes extend through the panel so that in unwrapping the suture,the surgeon may hold the reel-label with the thumb and a finger on eachside and touching throuch the hole to permit the reel-lable to rotateduring release of the suture. Preferably, the rotating hole is of arounded poly gon configuration. As shown, it is conveniently a diamondshaped hole with rounded corners. By having the hole other than round,the suture reel-labels may be mounted on a spindle and positively drivenby a nonround spindle which is shaped to match the rotating hole.Conveniently, a diamond shaped hole with rounded corners is used but ahexagonal, triangular, or other shaped hole may be used for the purposeif desired.

A separate needle protective cover 42 is cut from similar stiff labelpaper of 5 size and shape to nearly cover the face of the assembledpanels with a cover seal flap 43. The needle protective cover is sealedalong one edge to position the cover seal flap close to the face panelof the reel-label assembly, as shown in FIG. 5. One corner of the needleprotective cover is a lifting corner 44 which extends slightly beyond"the face panel so that it may be lifted by the thumb of the user.

Identifying indicia 45 may be printed on the needle protective cover.Conveniently, but not necessarily, a cover rotating hole 46 is formed inthe needle protective cover so that the cover may be either in theclosed position or in the open position as the reellabel is rotated tounwind a suture.

The needle protective cover may also be of a trans parent material, forexample, a mylar polyethylene laminate which permits inspection of theneedle and suture while protecting the needle and suture. If transparent, the identifying indicia may either be printed on the needleprotective cover or on the face panel of the reel-label.

In FIG. 7 is shown a curved needle 47 which is inserted through thecut-out notch of the tab 33 so that the needles extend between the taband the panel car. This keeps the needle away from the suture and holdsit in a positively oriented position until time of use. The suture 48extends from the curved needle 47 and is wound up and into the windingnotch 49 which winding notch is formed by the tabs sealed together inthe tab seal zones at the top and bottom and the accordion pleatedpanels on the edges. The suture may be wound in this winding notch bywrapping the suture in either direction with the free end being wounddown into the notch or left free. At the time of use, the needle may beremoved from its pocket and unwound with the turns of the suture passingeach other in the winding notch.

By having the suture fit in the winding notch 49 in such fashion thatturns can pass each other. the suture may be wound or unwound fromeither end at any time. This permits placing the needle 47 first, andwinding the suture in the winding notch without slack and yet withouttension. The needle pocket 50, which is formed by the cut-out for thetab 33 and the panel ear, permits a needle to be placed between twothicknesses of the panel stock and out of contact with the sutureindependently of whether the needle is curved. straight, triangular incross-section, or duck-billed with sharp sides, the needle pocketprovides a receptacle in which the point may be placed and the diagonalfrom the pocket is long enough for the entire needle to be placedbetween the face panel and the needle protective cover 42.

If the tabs 33 are narrower than the tab notches, the reel-label iseasier to assemble and has more resiliency. If the tab is slightlywider, the needle is necessarily more certainly diverted from passinginto the winding notch rather than being retained between the face paneland the face panel ear.

For those packages in which the suture is doublearmed, that is, has aneedle on each end, a pocket at the top and a pocket at the bottom canbe used, one for each needle. Alternatively, both needles may be placedin the same pocket.

In FIG. 8 is shown the suture wound between the accordion pleat panels.In this, as in other figures. the thickness of the panel stock isexaggerated for clarity.

The niceties of having the radii of curvature on the face panel and theback panel different in each corner and having all corners slightlyrounded, and slightly smaller so that even with manufacturingtolerances, none of the ears or accordion panels stick out enough tosnag the suture are features which are preferred for the best practiceof the invention. For many purposes, a less refined reel-label may beadequate.

The cover 42, as well as the paper stock from which the panels areformed, may be colored in order that the color of the reel-label give aclue as to the type of suture material wound around. Similarly, thesuture size, the suture material. and the type of needle may be printedon the needle protective cover on the face panel or the back panel.Usually. to avoid confusion, a minimum of printing is desirable in orderthat the user may very rapidly identify the data which is needed and notbe too confused with extraneous information.

The size of the reel-label is, of course, commensurate with the size ofthe suture and its needle. Conveniently, a face panel which is 2 7/16inches long and 1 /4inches wide gives good results. The radii ofcarvature of the back panel can conveniently be about a quarter of aninch whereas the smaller radius can be one-sixteenth inch and the largerradius three-eighths inch on the face panel with the earsone-sixty-fourth inch less on each corner. The accordion folds areconveniently a quarter of an inch for the first and second accordionpleat and a sixty-fourth of an inch more for the third accordion pleatpanel and a sixty-fourth of an inch less for the fourth accordion pleatpanel. Such a size permits sutures normally in use in a hospital to beconveniently packaged. For metric countries or where desired, panels maybe varied considerably in size to accommodate sutures of selected sizesand appropriate needles.

In FIG. 9 is shown the reel-label with the needle protective coverattached in a notched tearable inner envelope 51 in a strippable outerenvelope 55. The inner envelope may conveniently be made of a moistureproof material such as a 25 pound. calendered, bleached. pouch paperlaminated with about a half a mil of polyethylene to a metallic foilsuch as about a one mil aluminum foil which is again laminated to onemil polyethylene as an inner sealable layer. Such a material isdisclosed in U.S. Pat. No. 3,728,839, supra. Such material isessentially moisture proof so that synthetic absorbable sutures such asthose of polyglycolic acid are protected from hyrolytic degradation. Thesame material may be used for the packaging of catgut sutures which arepackaged with a desired quantity of water to maintain plasticity. Somesutures in which the moisture content is immaterial may be also packagedin the same material to maintain consistency of packaging standards.

By having a peaked sea] 53 and a tearing notch 52 therein, when theinner envelope is to be opened, the user can use the tearing notch as astart, and tear the laminate longitudinally along the face of thereel-label as shown in FIG. 10 so that without detaching the tornportion, the suture on the reel-label can be removed with forceps 54 orwith the gloved fingers to release the reel-label having the suturethereon for use.

The notched tearable inner envelope 51 is packaged in a strippable outerenvelope 55 of the type disclosed in U.S. Pat. No. 2,949,181, supra.

A modification of this invention is shown in FIG. 11. As shown in FIGS.15 and 16, a round reel 56 is formed from sealing together a round facepanel 57 and a round back panel 58 with an annular seal 59. The annularseal is inside the periphery ofthe face and back panels. As shown inFIG. 16, this leaves an external notch in which the suture is wound. Asshown in FIG. 15, a threading notch 60 is formed in at least one of thepanels in order that one or more needles 61 may be placed in an internalslit 62 with the suture 63 being wound into the winding notch formedbetween the round face panel and the round back panel.

From the constructional standpoint, the panels may be sealed togetherbefore the round face pane] and the round back panel are cut out fromlarger stock.

As shown in FIG. 16, conveniently, an X-ray opaque grommet 64 may beinserted to hold the panels together and also serve as a turning axisfor unreeling the suture. The metal grommet gives positive indication byX-ray ifa package is accidentally dropped into an incision during anoperation.

In FIG. 13 is shown a similar type of reel except that the face panelsare rectangular and long enough so that a straight needle 65 can beinserted into the retaining slit 66 with the rear end being held in apositioning slit 67. In this modification, an annular seal 68 is used tohold the panels together and a square hold 69 is used for a rotatableaxis. The square hole has the advantage that it may be used on a squaredrive shaft in winding 16 turns, depending on length, to wind a sutureonto the present reel-labels. It is convenient to have one or moresuture reel-labels ganged on a single spindle with the needles beinginserted into the needle pockets. All of the sutures are wound on thereels by mechanically turned spindles simultaneously. Gang windingpermits saving of time and effort, even though winding eight turns byhands is comparatively quick.

The use of rectangular reels gives a larger printing surface foridentification of the suture type, size, and needle. Additionally, itprovides a longer diagonal so that long straight needles can be insertedin the pocket and protected for their entire length. A rectangular reelpermits the use of a rectangular envelope which maintains theorientation so that the user can expect to find a needle in the samerelative position with respect to the envelope each time the sterileinner envelope is opened. This permits more raipd seizing of the needlewith needle forceps with positive knowledge that orientation is asplanned.

By having no sharp corners around which the suture is wound, evensutures which tend to attain a permanent set are curved minimally whenunreeled for use.

By using the cover and having the needle point between the face paneland a face panel ear, the needle is positively positioned and isprotected during winding so that the needle neither harms the suture northe envelope nor has its sharpness compromised during the assembly andstorage prior to actual use. The light frictional crimp from the sealedtogether panels permits as many as three sutures to be wound on a singlereel and yet each one can be positively unwound without tangling. Italso permits a longer length material to be wound for use as ligatures.

A radio opaque or magnetic grommet or ink permits detection of thepackage should it be inadvertently dropped into an incision.

By only having one part to the reel, the number ofextraneous pieces inthe operating theater are reduced. It permits more positive counting inand out of the operating room of each of the elements of packaging toinsure that all needles and extraneous items are accounted for before anincision is closed. The paper stock from which the panels are made, aswell as the envelope, are free from traps which would pick up and retaincontaminants and are readily sterilized by conventional sterilizingprocedures. The package is such that any sterilizing cycle which isadaptable to the suture may be used. The package, for instance, willstand heat, dry or wet, ethylene oxide, radiation, ultrasonic vibration,or other sterilizing agents or combinations of these. The reel-label andpackage are sufficiently sturdy that only the characteristics of thesuture material need to be considered as controlling parameters duringpackaging, sterilization, and storage.

Whereas, it is usually most convenient to cut the reellabel blank of HO.1 from strip material and fold on score lines to form the finishedreel-label, the face and back panels and accordion pleats as well asears may be cut from separate strips or cut out as separate panels andadhered together. For constructions such as shown in FIGS. 13 and 15where the edges of the panels extend beyond the annular seals, it isessentially necessary that separate panels be used. The feasibility ofusing folded panels is an alternative that must be placed in its propereconomic context with, of course, the cost of each method of operationbeing considered before the final decision is made.

The reel-label may be made of plastic, or a plastic laminate, or foam,or paper of unique characteristics as well as conventional label stock.

I claim:

1. A reel-label surgical suture combination comprismg two superimposedpanels of stiff sterilizable label stock having a heat sealable facingon one side;

said panels being rectangular, with rounded corners,

with the superimposed rounded corners having different radii;

accordion pleat folds joining the two panels on two parallel edges;

an infolded panel ear strengthening the top and bottom of each saidpanel;

cut-out tabs near the top and bottom of each panel,

said tabs being heat sealed to tabs from the opposing panel, to holdsaid panels together;

said panels each having therein a hole, said holes being inregistration, and forming a spin axis substantially at the center ofsaid panels;

said tabs and said accordion pleat folds forming a suture holdinggroove, to frictionally hold a suture therein;

said groove being effectively continuous and operatively centeredtowards said spin axis;

at least one of said panels having therein at least one needle retainingcut-out adapted to hold the sharp end of at least one needle betweenpanels in protective relationship;

a suture wound thereon, and at least in part in, said suture holdinggroove;

said suture having thereon an eyeless surgical needle,

the point of said needle being inserted in one of said needle retainingcut-outs;

and a needle protective cover adjacent to one of said panels on the sideopposite the other of said panels, covering and protecting said needle;

whereby the sharp portion of said needle is protected from dullingduring shipment and the suture and the package are protected from beingdamaged by the needle during packaging and shipment.

2. The reel-label surgical suture combination ofclaim l in which the twosuperimposed panels and the accordion pleat folds are formed from asingle flat piece of label stock.

3. The reel-label surgical suture combination of claim 1 in which thesurgical needle has sharp edges at the sides of the needle, which edgesare protected by said needle protective cover.

4. A suture package consisting of a sealed envelope and enclosed thereinat least one reel-label surgical suture combination as set forth inclaim I, and in which said needle protective cover protects the envelopefrom the sharp edges of the needle.

5. A double envelope suture package comprising a strippable outerenvelope having therein at least one suture package as set forth inclaim 4, and in which the said suture package is both interiorly andexteriorly sterile.

6. The reellabel ofclaim 1 in which at least a part of the reel-label isof an X-ray opaque material to provide for X-ray detection in a patient.

1. A reel-label surgical suture combination comprising two superimposedpanels of stiff sterilizable label stock having a heat sealable facingon one side; said panels being rectangular, with rounded corners, withthe superimposed rounded corners having different radii; accordion pleatfolds joining the two panels on two parallel edges; an infolded panelear strengthening the top and bottom of each said panel; cut-out tabsnear the top and bottom of each panel, said tabs being heat sealed totabs from the opposing panel, to hold said panels together; said panelseach having therein a hole, said holes being in registration, andforming a spin axis substantially at the center of said panels; saidtabs and said accordion pleat folds forming a suture holding groove, tofrictionally hold a suture therein; said groove being effectivelycontinuous and operatively centered towards said spin axis; at least oneof said panels having therein at least one needle retaining cut-outadapted to hold the sharp end of at least one needle between panels inprotective relationship; a suture wound thereon, and at least in partin, said suture holding groove; said suture having thereon an eyelesssurgical needle, the point of said needle being inserted in one of saidneedle retaining cut-outs; and a needle protective cover adjacent to oneof said panels on the side opposite the other of said panels, coveringand protecting said needle; whereby the sharp portion of said needle isprotected from dulling during shipment and the suture and the packageare protected from being damaged by the needle during packaging andshipment.
 2. The reel-label surgical suture combination of claim 1 inwhich the two superimposed panels and the accordion pleat folds areformed from a single flat piece of label stock.
 3. The reel-labelsurgical suture combination of claim 1 in which the surgical needle hassharp edges at the sides of the needle, which edges are protected bysaid needle protective cover.
 4. A suture package consisting of a sealedenvelope and enclosed therein at least one reel-label surgical suturecombination as set forth in claim 1, and in which said needle protectivecover protects the envelope from the sharp edges of the needle.
 5. Adouble envelope suture package comprising a strippable outer envelopehaving therein at least one suture package as set forth in claim 4, andin which the said suture package is both interiorly and exteriorlysterile.
 6. The reel-label of claim 1 in which at least a part of thereel-label is of an X-ray opaque material to provide for X-ray detectionin a patient.